Evaluation of the Effectiveness of a Psychoeducational Intervention on Benzodiazepine Use in the Population Over 64 Years Old in Primary Care

Not Applicable

Active, not recruiting

• Conditions: Benzodiazepines Deprescribing

• Registration Number: NCT06950567
• Lead Sponsor: Magi Claveria

Brief Summary

The objective of this pragmatic, multicenter, randomized controlled clinical trial is to determine whether an educational intervention regarding benzodiazepine use can reduce the consumption and/or dosage of these drugs in individuals over 64 years old.

It aims to provide knowledge and skills to help participants tolerate or reduce discomfort, enabling them to begin decreasing or discontinuing benzodiazepine (BZD) use.

The focus is on the effect of combined care, but the implementation of this approach is also assessed, providing valuable insights for further health developments in Primary Care.

Researchers will compare a minimal intervention, consisting of sending a "Benzoletter" to each participant's mailing address, with an intensive intervention that additionally includes psychoeducational sessions and therapeutic exercises.

Participants in the intervention group will attend sessions at the Primary Care Center for a total duration of eight weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Status Verified: 2025-04
• Primary Completion: 2025-04
• Study First Submitted: 2025-04-11
• Study First Submitted QC: 2025-04-25
• Last Update Submitted: 2025-04-25
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

• People over 64 years old who have been using benzodiazepines for a period of three months or more.
• People with an active diagnosis of anxiety and/or insomnia.

Exclusion Criteria

• People with psychiatric comorbidities, dementia, epilepsy, included in the home care program (ATDOM), institutionalized, or in palliative care.
• People with no possibility of contact or language barriers.
• People with difficulty traveling to the Primary Care Center (CAP).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants who have stopped taking benzodiazepines and/or have reduced their consumption measured in mg/week.	From the start of the intervention to six months afterward.

Trial Locations

Locations (1)

Primary Care Team of Alfarràs-Almenar.; 🇪🇸 Almenar, Lleida, Spain